evaluation of safety and efficacy of dm-28 for treatment of moderate to severe ocular dryness

Conditions: Dry Eye

Summary: this study is a pilot, exploratory study to check safety and efficacy of dm-28 device, a new medical device intended to treat moderate to severe ocular dryness.


Eligibility criteria:
inclusion criteria: * subject with a moderate to severe dry eye syndrome. * subject with a score ≥ 23 for the osdi (ocular surface disease index). * subject with at least one eye with: * global ocular staining (cornea and conjunctiva) ≥4 and ≤9 on the oxford scale (0 to 15) and one of the following criteria: * schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min or * sum of 3 measurements of tear film break-up time (tbut) ≤ 30s. * subject, having given freely and expressly his/her informed consent. * subject who is able to comply with the study requirements, as defined in the present cip, at the investigator's appreciation (investigator expertise). * subject being affiliated to a health social security system. * female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end (subject declaration). exclusion criteria: * far best corrected visual acuity (fbcva) \< 1/10 (according to snellen chart) * subject with severe ocular dryness with one of these conditions (investigator expertise): * eyelid or blinking malfunction * corneal disorders not related to dry eye syndrome * ocular metaplasia * filamentous keratitis * corneal neovascularization * subject with severe meibomian gland dysfunction (mgd) * history of ocular trauma, infection or inflammation, not related to dry eye syndrome within the last 3 months prior to the inclusion * history of ocular allergy or ocular herpes within the last 12 months. * any troubles of the ocular surface not related to dry eye syndrome. * subject with hypersensitivity to one of the components of the investigational device. * subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months. * use of the following systemic or ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs, corticoids or dry eye therapy (intense pulse light, stem cells) during the month preceding the inclusion. * subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start or expected to receive ocular therapy during the study. * any not stabilized systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation. * pregnant or nursing woman or planning a pregnancy during the study (subject declaration/ pregnancy test). * subject deprived of freedom by administrative or legal decision (subject declaration). * subject in a social or health institution (subject declaration). * subject who is under guardianship or who is not able to express his/her consent (subject declaration/ investigator expertise). * subject being in an exclusion period for a previous study (subject declaration). * subject suspected to be non-compliant according to the investigator's judgment (investigator expertise). * subject wearing contact lenses during the study